A Phase 1 Study of the Safety and Efficacy of CAR2 Anti-CD38 A2 CAR-T Cells in Patients with Relapsed or Refractory Multiple Myeloma

Trial Overview

What is the purpose of this trial?

This is an investigational study of CAR2 Anti-CD38 A2 CAR-T Cells in patients with Relapsed or Refractory Multiple Myeloma. The treatment uses your own T cells to try to kill your cancerous multiple myeloma cells. T cells fight infections and can also kill cancer cells in some cases. In this study, some of your T cells will be removed from your blood by a process called leukapheresis, changed in a laboratory, and then given back to you by intravenous (IV) infusion. While your T cells are in the laboratory, new genetic material will be put into your T cells. If your genetically changed T cells recognize and attach to multiple myeloma cells, the T cells may have the ability to become activated and kill the multiple myeloma cells.

The aim of this study is to find out:

The side effects of study therapy and if there are any side effects which prevent further use of study therapy in humans,

If there is any response of your multiple myeloma to treatment with study therapy,

How your body reacts to study therapy and how it moves in your body. For this purpose, the level of study therapy will be measured in your blood at specific intervals after you are given study therapy (this is called pharmacokinetics).

Learn more about this trial

If you meet all the criteria for being in the study, you will be entered into the study. The study is divided into the following 3 Periods: Screening, Treatment, and Observation.

Screening: The Screening Period is scheduled to take place within up to 43 days prior to receiving the study therapy and will includes the T cell collection visit. If the tests performed during the Screening Period show that you can take part in this study and your T cells grow in the laboratory so that there is an adequate number of cells available to give you an appropriate dose of study therapy, you will receive the dose of study therapy in 3 divided intravenous infusions.

Treatment: On Day 1 of the Treatment Period you will receive 10% of the dose, on Day 2 you will receive 30% of the dose, and on Day 3 you will receive 60% of the dose of study therapy. Each intravenous infusion will occur over 15 to 60 minutes. You may receive pre-medications such as Tylenol and Benadryl to help prevent a reaction to the infusion. After receiving the study therapy, you will be required to stay near to the hospital for the duration of the Treatment Period (Days 1 to 28 of the Treatment Period) to ensure rapid identification and rapid treatment of any side effects that you may experience that occur following the infusion of study therapy. You will be required to return for visits throughout the rest of the 28 day Treatment Period to be followed for safety and to perform further tests and procedures.

Observation: You will also be required to return for additional safety follow-up visits and procedures every 28 days for 5 months following the completion of the Treatment Period.

Long Term Follow-up: You will be asked to enroll into a long-term safety observation study at the End of Study visit or at your last study visit if you discontinue the study prior to the end of the Observation Period. All patients who have received modified T cell therapy regardless of the dose received will be contacted at least annually for follow-up. This follow-up visit may be by a clinic visit or by a telephone call. You will be asked about your general health and your multiple myeloma. The visit schedule for this long-term safety observation study will be every 2 months for 2 visits after the End of Study visit, then every 6 months up to year 5, and then yearly up to year 15.

Am I Eligible?

Have been treated with at least three prior lines of multiple myeloma therapy including a proteasome inhibitor, an immunomodulatory agent, and daratumumab

Have been treated and relapsed within 1 year of receiving HDT / ASCT in first of second line therapy

Must have evaluable disease

Must have a life expectancy of at least 12 weeks

Have not received anticancer therapy or investigational drug within 28 days of first dose

Have not received any approved anticancer chemotherapy within 21 days of first dose (exception cyclophosphamide as NMA conditioning)

Have not received allogenic hematopoietic stem cell transplantation (HSCT) within 6 months, does not have active graft-versus-host disease (GVHD) following transplant, or has not received immunosuppressive therapy following a transplant

Have not received any prior CAR-T or CAR-T cell line therapies

The following criteria is provided for health care professionals.

Inclusion Criteria:

Must have relapsed or refractory multiple myeloma after receiving greater than or equal to 3 lines of therapy and relapsed within 1 year of 1st/2nd line treatment

Must have evaluable disease

Must have a life expectancy of at least 12 weeks

Subjects should be willing and able to comply with the study schedule and protocols

Females of childbearing potential must have 2 negative pregnancy tests, agree to ongoing pregnancy testing during the study, and sexually active female and male subjects must be willing to use an effective method to avoid pregnancies.

Exclusion Criteria:

Subjects who received anticancer therapy or investigational drug within 28 days of first dose

Subjects who received any approved anticancer chemotherapy within 21 days of first dose (exception cyclophosphamide as NMA conditioning)

Has received allogenic hematopoietic stem cell transplantation (HSCT) within 6 months, have active graft-versus-host disease (GVHD) following transplant, or receiving immunosuppressive therapy following a transplant

Has any clinically significant elevated baseline lab results for serum creatinine, AST, and total bilirubin (except for patients in whom hyperbilirubinemia is attributed to Gilbert's syndrome) at screening regardless of causality.

Known HIV or acquired immunodeficiency syndrome-related illness, acute or history of chronic hepatitis B or C.

Female subjects who are pregnant or breastfeeding

Active bacterial, viral or fungal infections

Has plasma cell leukemia

Has medical condition, abnormality, or psychiatric illness that would prevent study participation

Left ventricular ejection fraction (LVEF) < 40%

Call Us Today

Call us at (888) 828-2206 and we can answer any questions and help get you connected with this study team.

Create Your Free Account

Our system will analyze your profile against hundreds of clinical trials to find ones that may be right for you.